BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM NEGATIVE ID TEST KIT

    MDR report key: 6948959 · Received October 13, 2017

    Report

    Report Number
    1950204-2017-00340
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Report Date
    March 23, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LQM
    UDI-DI
    03573026131913
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF ESCHERICHIA COLI IN ASSOCIATION WITH VITEK® 2 GN ID TEST KIT (REF 21341, LOT 2410112103). THE VITEK® 2 GN CARD HAD IDENTIFIED THE ISOLATE AS ESCHERICHIA COLI 0157 ON THE FIRST RUN AND SECOND RUN OF TESTING. THE THIRD RUN GAVE AN IDENTIFICATION OF ESCHERICHIA COLI ONLY. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER DID NOT HAVE THE ISOLATE OR RAW DATA TO SUBMIT FOR EVALUATION. THE CUSTOMER REPORTED SETTING UP THE STRAINS FROM HOME MADE BLOOD AGAR AND INCUBATING AT 36C IN 5% CO2. NO OTHER SET UP INFORMATION WAS PROVIDED. CO2 IS NOT A RECOMMENDED CULTURE ENVIRONMENT ACCORDING TO THE GN PRODUCT LABELING. NO LAB REPORTS WERE SUBMITTED FOR THIS MISIDENTIFICATION; THEREFORE, NO FURTHER EVALUATION CAN BE MADE FOR THESE COMPLAINTS. AN INCREASED NUMBER OF ATYPICAL NEGATIVE RESULTS CAN INDICATE A STRAIN WITH DECREASED VIABILITY, USER SET UP ERROR OR AN ATYPICAL STRAIN. WITHOUT THE STRAINS, RAW DATA OR LAB REPORTS IT'S NOT POSSIBLE TO FURTHER EVALUATE THE CAUSE OF THE MISIDENTIFICATION. VITEK 2 GN LOT # 2410112103 MET FINAL QC RELEASE CRITERIA. THIS LOT PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF ESCHERICHIA COLI IN ASSOCIATION WITH VITEK® 2 GN ID TEST KIT (REF 21341, LOT 2410112103). THE VITEK® 2 GN CARD HAD IDENTIFIED THE ISOLATE AS ESCHERICHIA COLI 0157 ON THE FIRST RUN AND SECOND RUN OF TESTING. THE THIRD RUN GAVE AN IDENTIFICATION OF ESCHERICHIA COLI ONLY. THE CUSTOMER PERFORMED API20E AND API32E TESTING WITH DIFFERENT RESULTS AS WELL. API20E RESULT: E. COLI (SORBITOL POSITIVE) AND API32E RESULT: E. COLI (SORBITOL NEGATIVE). THE RESULT WAS FINALLY CONFIRMED WITH A SORBITAL MCCONKEY AGAR AS SORBITAL POSITIVE. THE CUSTOMER REPORTED USING AGAR THAT IS PRODUCED INTERNALLY. THE CUSTOMER REPEATED TESTING WITH AN ISOLATE GROWN ON COMMERCIAL, PRE-PLATED AGAR, AND THEY RECEIVED THE SAME MISIDENTIFICATION RESULT. THE CUSTOMER STATED THAT THERE WAS NO INCORRECT TREATMENT OR DELAY, AND THERE WAS NO HARM TO THE PATIENT. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727698 VITEK® 2 GRAM NEGATIVE ID TEST KIT VITEK® 2 GN ID TEST KIT LQM BIOMERIEUX, INC. 2410112103 03573026131913

    Patients

    Seq Age Sex Outcome Treatment
    1